Cleared Traditional

BACTEC MGIT 960 PZA KIT

K021582 · Becton, Dickinson & CO · Microbiology
Jul 2002
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K021582 is an FDA 510(k) clearance for the BACTEC MGIT 960 PZA KIT, a Susceptibility Test Powders, Antimycobacterial (Class II — Special Controls, product code MJA), submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on July 13, 2002, 60 days after receiving the submission on May 14, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K021582 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2002
Decision Date July 13, 2002
Days to Decision 60 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MJA — Susceptibility Test Powders, Antimycobacterial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640